Identity
- Trade Name
- Albumin BCP (6x50 mL) FDA UDI
- Generic Name
- Albumin IVD, reagent FDA UDI
- Device Name
- The Albumin BCP (6x50 mL) assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. The assay is intended for professional use only. For In Vitro Diagnostic use only. FDA UDI
- Model / Reference
- C22856 FDA UDI
- Description
- The Albumin BCP (6x50 mL) assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. The assay is intended for professional use only. For In Vitro Diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- C22856 FDA UDI
- Primary DI / UDI-DI
- 08058056681980 FDA UDI
- 510(k) Number
- K193001 FDA UDI
- FDA Product Code
- CJW FDA UDI
- GMDN Term
- Albumin IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1035 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 300 Milliliter FDA UDI
Category: Albumin IVD, reagent
Albumin BCP (6x50 mL) by Sentinel Ch. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sentinel Ch. Srl
Sources (1)
- FDA UDI 8ab4ae46-0b85-4cba-afa9-43cf96c9cda3 38 fields · synced May 30, 2026